[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.407]

[Page 78-79]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 5_DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents
 
  Subpart F_Medical Devices and Radiological Health; Redelegations of 
                                Authority
 
Sec. 5.407  Approval, disapproval, or withdrawal of approval of product 

development protocols and applications for premarket approval for medical 
devices.

    (a) The following officials, for medical devices assigned to their 
respective organizations, are authorized to approve, disapprove, declare 
as complete or incomplete, or revoke product development protocols for 
medical devices submitted under section 515(f) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(f)):
    (1) The Director and Deputy Directors for Science and for 
Regulations

[[Page 79]]

and Policy, Center for Devices and Radiological Health (CDRH), the 
Director and Deputy Directors, Office of Device Evaluation (ODE), CDRH, 
and the Division Directors, ODE, CDRH.
    (2) The Director and Deputy Directors, Center for Biologics 
Evaluation and Research (CBER), and the Director and Deputy Directors, 
Office of Blood Research and Review (OBRR), Office of Vaccines Research 
and Review (OVRR), and Office of Therapeutics Research and Review 
(OTRR), CBER.
    (b)(1) The following officials, for medical devices assigned to 
their respective organizations, are authorized to approve, disapprove, 
or withdraw approval of applications for premarket approval for medical 
devices submitted under sections 515 and 520(l) of the act (21 U.S.C. 
360e and 360j(l)):
    (i) The Director and Deputy Directors for Science and for 
Regulations and Policy, CDRH, the Director and Deputy Directors, ODE, 
CDRH, and the Division Directors, ODE, CDRH.
    (ii) The Director and Deputy Directors, CBER, and the Directors and 
Deputy Directors, OBRR, OVRR, and OTRR, CBER.
    (2) For medical devices assigned to their respective division, the 
Division Directors, Office of Device Evaluation, CDRH, are authorized to 
approve, disapprove, or withdraw approval of supplemental premarket 
applications.
    (c) The Director and Deputy Directors for Science and for 
Regulations and Policy, CDRH, for medical devices assigned to their 
organization, are authorized to issue notices to announce the approval, 
disapproval, or withdrawal of approval of a device, and to make publicly 
available a detailed summary of the information on which the decision 
was based, under sections 515(d), (e), and (g) and 520(h)(1) of the act 
(21 U.S.C. (d), (e), and (g) and 360j(h)(1)).
    (d) These officials may not further redelegate these authorities.